Pharmacovigilance Specialist II
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
Participates in activities related to, and reporting of Adverse Events for BioMarin post marketed products and investigational products being assessed in clinical studies. Contributes to departmental clinical study activities and risk management activities as needed.
- Triage all incoming reports for initial assessment of seriousness, expectedness, causality and reportability)
- Data entry into the global safety database including generation of medical narratives
- Responsible for determining and performing active follow up for all case types
- Performs review and assessment of the validity of literature abstracts and articles
- Participate as the PV representative in Project Team Meetings for assigned projects (including protocol and ICF review, development of SRPs, Safety Reporting presentations at Investigator Meeting and reconciliation activities)
- Conduct reconciliation of serious adverse events between drug safety and clinical trial database for ongoing clinical studies
- Develop and maintain product and disease state knowledge for all Company products
- Ensure departmental workflow processes and timelines are followed
- Assure and maintain compliance with regulatory and local/global timelines
- Provide training and mentoring to new PV staff (if applicable)
- Health care professional degree required (RN, BSN, PA, NP, PharmD or MD)
- Minimum of 3-5 years Pharmacovigilance experience.
- Previous experience with safety database application(s)
- Thorough knowledge of medical terminology essential.
- Strong knowledge of MedDRA
- Knowledge of Pharmacovigilance and processes, knowledge of appropriate regulations and related timelines
- Skill requirements: ability to work in a team environment, strong organization skills, detail oriented, meet tight deadlines, strong communication skills both verbal and written, demonstrate computer proficiency, demonstrated initiative and accountability.
- Strong knowledge of internal medicine, epidemiology, physiology and pharmacology
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.